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Morris Medical Monday: Work Item type 'Feedback' in Polarion's MedPack Extension

By morrisd

Welcome back to Morris Medical Monday: a weekly series for medical device development companies (and companies who are related to such companies), providing some useful information about Polarion solutions and Polarion extensions.

Today we will continue on the subject of Polarion’s MedPack extension, and have a look into MedPack’s Feedback Work Item type.


Feedback


Description


User or market feedback according to clause 6.2.1.2 of IEC 62304:2006. A feedback entry might have a link to a problem report generated from it.

Workflow Steps


The Feedback Item uses the standard Evaluation Workflow.

EvaluationWorkflow_Overview

Traceability & Impact


A Feedback Work Item has an impact on a Problem Report.
For more information on traceability and impacts, see the Traceability wiki page.

Attributes


Work Item Attributes


The following custom fields must be filled out before evaluation can be requested:















Attribute Name Type Description
Feedback source Enum A Feedback has to be classify in the the following “feedback source”-categories:
– inside organisation
– outside organisation (customer)
– outside organisation (user)
(as required by IEC 62304:2006->6.2.1.1).

Evaluation Attributes


The following custom fields must be filled out before evaluation can be finshed and the work item can be closed:

























Attribute Name Type Description
Reviewer Text Person(s) to perform, performing or have performed a review.
Review summary Text Short summary of the review. Attachments should be used for additional information.
Last review date Date Hidden field automatically set when review has been finshed. Intended to be used for sorting and statistical analysis.

Evaluation Checklist


The following checklist must be filled out before evaluation can be finshed and the work item can be closed:







Checklist entry Description

Possible Resolutions


The following table shows the possible resolution values when the work item is closed:





















Resolution Name Description
Needs Problem Report Further investigation through a problem report is needed for this feedback (as required by IEC 62304:2006->6.2.1.2).
No Problem Report Needed No further investigation through a problem report is needed for this feedback.
Discarded The work item entry has been discarded. No further attention is needed.

 

For more information about Polarion’s MedPack visit our Extension Portal using following link:
http://extensions.polarion.com/extensions/31-polarion-alm-medpack-iec-62304. I hope you liked this article and you will visit our Blog again when there is another Morris Medical Monday article.



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This article first appeared on the Siemens Digital Industries Software blog at https://blogs.sw.siemens.com/polarion/morris-medical-monday-work-item-type-feedback-in-polarions-medpack-extension/